CONDITIONS GOVERNING THE PREPARATION, PLACING ON THE MARKET AND USE OF MEDICATED FEEDINGSTUFFS RULES *

OF MEDICATED FEEDINGSTUFFS

SUBSIDIARY LEGISLATION 437.73

CONDITIONS GOVERNING THE PREPARATION,

PLACING ON THE MARKET AND USE OF

MEDICATED FEEDINGSTUFFS RULES *

17th June, 2005

LEGAL NOTICE 225 of 2005.

(1) The title of these rules is the Conditions governing the

Preparation, Placing on the Market and Use of Medicated

Feedingstuffs Rules.

(2) These rules lay down, without prejudice to the adoption of

the list laid down in Article 3, point 1, second sub-paragraph, to

European Union Directive 2001/82/EC, the conditions other than

those of animal health, governing the preparation, placing on the

market and use of medicated feedingstuffs within the territory of

Malta.

(3) These rules shall not affect European Community rules

applicable to additives used in feedingstuffs, or national rules

adopted pursuant to the said rules, and in particular those

applicable to the additives referred to in Article 1, second sub-

paragraph, to European Union Council Directive 90/167/EC.

(4) The scope of these rules is to implement the rules found

under the European Union Council Directive of the 26th March,

1990 laying down the conditions governing the preparation, placing

on the market and use of medicated feedingstuffs in the

Community.

(1) For the purposes of these rules the definitions

appearing in Article 1 of European Union Directive 2001/82/EC of

the European Parliament and of the Council of 6 November 2001

on the Community code relating to veterinary medicinal products

and Article 2 of Council Directive 79/373/EEC of 2 April 1979 on

the marketing of compound feedingstuffs, as last amended by

Directive 2000/16/EC of the European Parliament and the Council

of 10 April 2000 shall apply as necessary.

(2) For the purposes of these rules, the following definitions

shall also apply

"authorized medicated pre-mix" means any pre-mix for the

manufacture of medicated feedingstuffs as defined in Article 1,

point 5, of European Union Directive 2001/82/EC which has been

granted an authorization in accordance with Articles 5, 6, 7, 8, 9,

10, and 11 of that Directive;

"Member State" means a State which is a Member within the

European Community;

*These regulations have been repealed by Legal Notice 266 of 2024.

OF MEDICATED FEEDINGSTUFFS

"placing on the market" means the holding in the territory of the

Community for sale or disposal in any other form whatever to third

parties, whether or not for consideration, and actual sale or

disposal;

"the Commission" means the European Union Commission;

"the Community" means the European Community;

"Third Country" means a State which is not a Member within the

European Community;

"Veterinary Services" means the competent authority within the

territory of Malta as established under article 2 of the Veterinary

Services Act.

(1) The Veterinary Services shall prescribe that, as regards

t h e m ed i c i n a l c o m p o n e n t , m ed i c a t e d f e e d i n g s t u ff s m a y b e

manufactured from authorized medicated pre-mixes only.

(2) By way of derogation from sub-rule (1), the Veterinary

Services may, provided they comply with the requirements of

Article 6 of European Union Directive 2001/82/EC

(a) subject to any specific conditions laid down in

authorizations to place authorized medicated pre-

mixes on the market, authorize intermediate products

which are prepared from such medicated pre-mixes

authorized in accordance with Article 6, 7, 8, 9, 10,

and 11 of European Union Directive 2001/82/EC and

from one or more feedingstuffs and which are intended

for the subsequent manufacture of medicated

feedingstuffs ready for use;

(b) the Veterinary Services shall take all necessary steps to

ensure that intermediate products are manufactured

only by establishments authorized in accordance with

rule 4 and that they are the subject of a declaration to

the Veterinary Services, authorize the veterinarian to

have manufactured under the conditions laid down in

Article 4(3) of Directive 81/851/EEC, and under his

responsibility and on prescription, medicated

feedingstuffs from several authorized medicated pre-

mixes, provided that there is no specific authorized

therapeutic agent in pre-mix form for the disease to be

treated or for the species concerned;

(c) until the date on which the Veterinary Services has to

comply with the new rules laid down in Article 9 of

European Union Directive 2001/82/EC, national rules

governing the above conditions shall remain

applicable, with due regard to the general provisions

of the Treaty.

(3) Products authorized pursuant to sub-rule (1) shall be

subject to the rules laid down in Articles 44 to 63 of European

Union Directive 2001/82/EC.

OF MEDICATED FEEDINGSTUFFS

(1) The Veterinary Services shall take all necessary

measures to ensure that medicated feedingstuffs are manufactured

only under the conditions set out below

(a) the manufacturer shall have premises which have been

previously approved by the competent national

authority, technical equipment and suitable and

adequate storage and inspection facilities;

(b) the medicated feedingstuffs manufacturing plant shall

be manned by staff whose knowledge of and

qualifications in mixing technology are adequate;

(c) the producer shall be responsible for ensuring that

(i)

only feedingstuffs or combinations thereof

which comply with Community provisions on

feedingstuffs are used,

(ii) the feedingstuff used produces a homogeneous

and stable mix with the authorized medicated

pre-mix,

(iii) the authorized medicated pre-mix is used during

the manufacturing process in accordance with

the conditions laid down when authorization for

placing on the market was given and, in

particular, that

(1) there is no possibility of any undesirable

interaction between veterinary medicinal

products, additives and feedingstuffs;

(2) the medicated feedingstuff will keep for

the stipulated period;

(3) the feedingstuff to be used for producing

the medicated feedingstuff does not

contain the same antibiotic or the same

coccidiostat as those used as an active

substance in the medicated pre-mix;

(iv) the daily dose of medicinal product is contained

in a quantity of feedingstuff corresponding to at

least half the daily feed ration of the animals

treated or, in the case of ruminants,

corresponding to at least half the daily

requirement of nonmineral supplementary

feedingstuffs;

(d) premises, staff and equipment used and participating

in the entire manufacturing process must comply with

the manufacturing hygiene rules and principles of the

Member State in question; the manufacturing process

must conform to the rules of good manufacturing

practice;

(e) the medicated feedingstuffs manufactured shall

undergo regular checks, including appropriate

laboratory tests of homogeneity by the manufacturing

establishments, under the supervision and periodic

control of the official department, to ensure that the

OF MEDICATED FEEDINGSTUFFS

medicated feedingstuff complies with the requirements

of these rules, especially in respect of its homogeneity,

stability and storability;

(f)

manufacturers shall be obliged to keep daily records of

the types and quantities of the authorized medicated

pre-mixes and feedingstuffs used and of the medicated

feedingstuffs manufactured, held or dispatched,

together with the names and addresses of the breeders

or holders of the animals, and in the case provided for

in rule 10(2), the name and address of the authorized

distributor and, where appropriate, the name and

address of the prescribing veterinarian. The records,

which must meet the requirements of Article 12 and

Article 13(1) of European Union Directive 2001/82/

EC, must be kept for at least three years after the date

of the last entry and must be made available at any

time to the competent authorities in case of checking;

(g) pre-mixes and medicated feedingstuffs shall be stored

in suitable separate and secured rooms or hermetic

containers which are specially designed for the storage

of such products.

(2) The Veterinary Services may, by way of derogation from

sub-rule (1), subject to any additional guarantees as appropriate,

authorize the manufacture of medicated feedingstuffs on farms

provided that the said sub-rule (1) is complied with.

(1) The Veterinary Services shall prescribe that medicated

feedingstuffs may be placed on the market only in packages or

containers sealed in such a way that, when the package is opened,

the closure or seal is damaged and they cannot be re-used.

(2) Where road tankers or similar containers are used to place

medicated feedingstuffs on the market, these must be cleaned

before any re-use in order to prevent any subsequent undesirable

interaction or contamination.

(1) The Veterinary Services shall take all necessary

measures to ensure that medicated feedingstuffs are not put into

circulation unless the labelling complies with the European

Community provisions in force. Furthermore, the packages or

c o n t a i n e r s r e f e r r e d t o i n r u l e 5 ( 1 ) s h a l l b e cl e a r l y m a r k e d

"Medicated Feedingstuffs".

(2) Where road tankers or similar containers are used to place

medicated feedingstuffs on the market, it shall be sufficient for the

information referred to in sub-rule (1) to be contained in the

accompanying documents.

(1) The Veterinary Services shall take all necessary

measures to ensure that a medicated feedingstuff cannot be held,

placed on the market or used unless it has been manufactured in

accordance with these rules.

OF MEDICATED FEEDINGSTUFFS

(2) Subject to the requirements of Article 6 of European Union

Directive 2001/82/EC with regard to the tests to be carried out on

veterinary medicinal products, the Veterinary Services may,

however, for scientific purposes, provide for derogations from

these rules, provided there is adequate official control.

(1) The Veterinary Services shall ensure that medicated

feedingstuffs are not supplied to stockfarmers or holders of animals

except on presentation of a prescription from a registered

veterinarian on the following terms

(a) the veterinarian’s prescription shall be made out on a

form shown on the specimen in Schedule I; the

original form shall be for the manufacturer or, where

appropriate, a distributor approved by the competent

authority of the Member State of destination of the

medicated feedingstuffs;

(b) the veterinarian shall fill Part A of the following

prescription and copies of prescription shown in

Schedule I

(i)

manufacturer’s or authorised distributors

original, which shall be retained by the

manufacturer or authorised distributor for a

period which is not less than three years from

date when the prescription was filled by the

veterinarian. The veterinarian shall omit the

details of the disease for which the treatment is

prescribed in Part A of this original. The

manufacturer or authorised distributor shall fill

Part B of this original. This prescription shall be

made available at all times to the Veterinary

Services during official inspections;

(ii) Food and Veterinary Regulation Division copy

which shall be sent by the manufacturer or

authorised distributor to the Veterinary Services

within five days of the presentation of the

prescription. The veterinarian shall omit the

disease for which the treatment is prescribed in

Part A of this copy. The manufacturer or

authorised distributor shall fill Part B of this

copy;

(iii) the veterinarian’s copy which shall be retained

by the veterinarian for a period of not less than

three years from the date the prescription was

made by him. The disease to be treated shall

only be indicated in Part A of this copy. This

prescription copy shall be made available at all

times to the Veterinary Services during official

inspections;

(c) medicated feedingstuffs may not be used for more than

one treatment under the same prescription;

(d) the veterinary prescription shall be valid only for a

OF MEDICATED FEEDINGSTUFFS

period determined by the Veterinary Services which

shall not exceed three months from the date on which

the prescription is made by the veterinarian;

(e) the veterinarian’s prescription may be used only for

animals treated by him. The veterinarian must first

satisfy himself that

(i)

the use of this medication is justified for the

species concerned on veterinary grounds;

(ii) administration of the medicinal product is not

incompatible with a previous treatment or use

and that there is no contra-indication or

interaction where several pre-mixes are used;

(f)

the veterinarian must

(i)

prescribe the medicated feedingstuffs only in

such quantities as, within the maximum limits

laid down by the national authorization for

placing medicated pre-mixes on the market, are

necessary for the purpose of the treatment;

(ii) satisfy himself that the medicated feedingstuff

and the feedingstuff currently used to feed

treated animals do not contain the same

antibiotic or the same coccidiostat as active

substances.

(2) However, in the case of anthelmintic medicinal products

(vermifuges), the Veterinary Services may, pending the review to

be carried out under European Union Directive 2001/82/EC of the

risks associated with the use of these groups of substances,

derogate for five years after the adoption of these rules from the

obligation laid down in sub-rule (1) not to supply medicated

feedingstuffs obtained from authorized medicated pre-mixes except

on presentation of a veterinary prescription, provided that

(a) the medicated pre-mixes used do not contain active

substances which belong to the chemical groups used,

in the territory of Malta, on medical prescription for

human medicine,

(b) the

medicated

feedingstuffs

accorded

such

authorization are used in their territory only

prophylactically and in the dosages necessary for the

purpose in question.

(3) The Veterinary Services shall inform the European Union

Commission and the other Member States within the Standing

Veterinary Committee of the application of such a derogation,

specifying in particular the nature of the medicinal products and

animal species that it covers.

(4) Where medicated feedingstuffs are administered to animals

whose meat, flesh, offal or products are intended for human

consumption, the stockfarmer or holder of the animals concerned

must ensure that treated animals are not slaughtered in order to be

offered for consumption before the end of the withdrawal period

OF MEDICATED FEEDINGSTUFFS

and that products obtained from a treated animal before the end of

such a withdrawal period are not disposed of with a view to their

being offered for human consumption.

(1) The Veterinary Services shall take all necessary

measures to ensure that medicated feedingstuffs are issued directly

to the stockfarmer or holder of the animals only by the

manufacturer or distributor specially approved by the competent

authority of the Member State of destination.

(2) Furthermore, medicated feedingstuffs for the treatment of

animals whose meat, flesh, offal or products are intended for

human consumption may not be issued unless

(a) they do not exceed the quantities prescribed for the

treatment, in accordance with the veterinary

prescription where this is provided for,

(b) they are not issued in quantities greater than one

month’s requirements as established in accordance

with the stipulations of paragraph (a).

(3) However, notwithstanding sub-rule (1), the Veterinary

Services may in special cases authorize distributors specifically

approved for that purpose to issue, on the basis of a veterinary

prescription, medicated feedingstuffs in small quantities, prepacked

and ready for use, and prepared, without prejudice to rule 8(2) in

accordance with the requirements of these rules, provided that

these distributors

(a) comply with the same conditions as the manufacturer

regarding the keeping of registers and the storage,

transport and issue of the products concerned,

(b) are subject to special checking for the purpose, under

the supervision of the competent veterinary authority,

(c) may supply only prepacked or prepackaged medicated

feedingstuffs ready for use by the holder or

stockfarmer that have on the packaging or containers

instructions for the use of the said medicated

feedingstuffs and, in particular, an indication of the

withdrawal period.

(4) The provisions of sub-rule (2) shall not affect national rules

on the legal ownership of the medicated feedingstuffs.

(1) The Veterinary Services shall ensure that, without

prejudice to animal-health rules, there are no prohibitions,

limitations or obstacles in respect of intra-Community trade

(a) in medicated feedingstuffs which have been

manufactured in accordance with the requirements of

these regulations, and in particular rule 4, with

authorized premixes which have the same active

substances as pre-mixes authorized by the Member

State of destination, in accordance with the criteria of

European Union Directive 2001/82/EC, and a

quantitative and qualitative composition similar

OF MEDICATED FEEDINGSTUFFS

thereto,

(b) subject to the specific provisions of European Union

Council Directive 96/23/EC of 29 April 1996 on

measures to monitor certain substances and residues

thereof in live animals and animal products and

repealing Directives 85/358/EEC and 86/469/EEC and

Decisions 89/187/EEC and 91/664/EEC and Council

Directive 96/22/EC of 29 April 1996 concerning the

prohibition on the use in stockfarming of certain

substances having a hormonal or thyrostatic action and

of b-agonists, and repealing Directives 81/602/EEC,

88/146/EEC and 88/299/EEC as referred to in Article

7(1) of Council Directive 96/22/EC, in animals to

which those medicated feedingstuffs except those

produced pursuant to rule 3(2), have been

administered, or in meat, flesh, offal or their products

from such animals.

(2) Where the application of sub-rule (1) gives rise to dispute,

in particular as concerns recognition of the similar nature of the

pre-mix, the Member States concerned or the Commission may

submit the dispute to assessment by an expert appearing on a list of

Community experts to be drawn up by the Commission on a

proposal from the Member States. If the two Member States so

agree beforehand, the parties shall abide by the opinion of the

expert, in compliance with Community legislation.

(3) The Member State of destination may require that each

consignment of a medicated feedingstuff be accompanied by a

certificate issued by the competent authority, corresponding to the

specimen form in Schedule II.

(1) The safeguard measures laid down by European Union

Council Directive 89/662/EEC shall apply to trade in authorized

medicated pre-mixes or medicated feedingstuffs.

(2) The rules laid down concerning veterinary control and, in

particular, the requirements laid down in Article 5(2) and Article

20 of European Union Council Directive 89/662/EEC shall apply to

trade in authorized pre-mixes or medicated feedingstuffs to the

extent that they are subject to veterinary control.

The Veterinary Services shall take all necessary measures

to ensure compliance to these rules

(a) by making sampling checks at all stages of the

production and marketing of the products referred to

by these rules, to ensure that the provisions of these

rules are complied with;

(b) in particular, by making sampling checks on farms and

slaughterhouses,

to

ensure

that

medicated

feedingstuffs are used in compliance with the

conditions of use, and that withdrawal periods have

been complied with.

OF MEDICATED FEEDINGSTUFFS

Pending the implementation of Community measures

relating to imports of medicated feedingstuffs from third countries,

the Veterinary Services shall apply to those imports measures

which are at least equivalent to those of these rules.

OF MEDICATED FEEDINGSTUFFS

Schedule I

OF MEDICATED FEEDINGSTUFFS

OF MEDICATED FEEDINGSTUFFS

OF MEDICATED FEEDINGSTUFFS

Schedule II

ACCOMPANYING CERTIFICATE IN RESPECT

OF MEDICATED FEEDINGSTUFFS FOR ANIMALS INTENDED FOR TRADE

Name and address of the manufacturer or approved distributor: .............................

Name of the medicated feedingstuff: .....................................................................

Type of animal for which the medicated feedingstuff is intended: ..........................

Name and composition of the authorised medicated pre-mix: ................................

Dosage of the medicated pre-mix authorised in the medicated feedingstuff: ...........

Quantity of medicated feedingstuff: ......................................................................

Name and address of the recipient: ........................................................................

It is hereby certified that the medicated feedingstuff as described above has been

manufactured by an authorised person in accordance with Directive 90/167/EEC.

Done at ............................................, on .............................................

(place)

(date)

(Signature)

(Name and position)

Stamp of the veterinary authority

or other competent authority